Create a Value Set for the Predefined Filter

1. Specify values for the filter elements in the sections.

   Depending on the filter you selected, the FILTER VALUE SET page may contain these sections:

   Sections in the New FILTER VALUE SET Page	Associated Elements (Fields)
   Case Information	Case Followup Receipt Date Case Initial Receipt Date Case Report Type Event Listedness/Lic Country Family Name Owned by Site Product Project/Study
   Patient Information	BMI Patient Age Group Patient Age (In Years) Patient Gender/Pregnancy Patient Ethnicity
   Product Information	ATC Code Drug Primary Indication Code Product Rechallenge/Dechallenge Regimen Daily Dose Total Drug Dosage Total Regimen Dosage
   Event Information	Event Seriousness Event Term Event Listedness/Lic Country Onset Latency (minutes) Outcome of Event Related to Study Conduct? (As Reported)
   Workflow Information	Case Delayed/Open Case Status Has Followup Workflow Group
   Miscellaneous Information	Lab Results Lab Test/Assessment
   Report Information	Report Agency Report Form Report Submission Date Reports Pending Reporting Group

   Note:

   To access the MedDRA Browser from the Pharmacovigilance or Workflow filters, navigate to Queries > Filters > New Value Set. The MedDRA Browser for the Pharmacovigilance and Workflow filters support the following options specific to filters:

   • All hierarchy option — Use this option to enable a query search based on all/selected hierarchical terms in MedDRA. The search output captured depends on the check boxes selected in the MedDRA Browser window.

   • Term only option — Use this option to select multiple terms within a specific AE term. Click on the term(s) you want to include in your search criteria. These terms are highlighted in yellow. The output based on the term(s) selected in the MedDRA Browser is populated in the relevant section of the filter.

2. Examine the value set results.
3. Click Execute.

   While the system searches for matching cases, the following dialog box appears:

   Tip:

   To cancel the query execution at this point and return to the FILTER VALUE SET page, click Cancel Query.

   If the system finds cases that match the query criteria, the list of cases appear on the ACTIVE CASE SERIES page.

4. Examine the case series. If the case series is too large, you may want to modify the value set to narrow down the case series.

   Alternatively, if you find the case series to be appropriate, you can save the value set to the system.

5. Click View Query in the ACTIVE CASE SERIES page to return to the FILTER VALUE SET page.

   Note:

   When you save the modifications to a value set or execute a value set, the system assigns the active status to the value set. Therefore, when you return to the VALUE SET page, the Active Query Name label displays the name of the filter.
6. If required, modify the value set and examine the results again or proceed to save the value set.
7. Save the value set to the system.
8. In the Description field, enter a description of the value set.

   For example, you may describe the type of cases the value set retrieves.

9. Click Save Values.

   The Save Value Set dialog box appears.

10. In the Name field, enter the name of the value set.
11. Click OK to close the dialog box and refresh the FILTER VALUE SET page.

    Note that:

    • The Name label displays the name of the value set you specified.
    • The Save Values As button and the Permissions button are now enabled.

    Note:

    The FILTER LIBRARY page displays all the value sets saved to the system. See "Work with Saved Filters and Value Sets" for more information.

    Tip:

    If you make modifications to the field values after you saved the value set to the system, click Save Values to save the changed field values. To save the value set by another name, click Save Values As. To clear all the field values in the FILTER VALUE SET page, click Clear.
12. To assign group-level permissions on the saved value set, click Permissions.

    The Permissions dialog box appears with the names of all the groups (except the Administrator group) that the system administrator has created.

13. To assign permissions to the group members on the value set you have created, use the drop-down list next to a group name.

    The available options are:

    Permission	Description
    R/W/D/P	Group members will be able to view, modify, delete, and assign permission on the value set.
    R/W/D	Group members will be able to view, modify, and delete the Value Set.
    R/W	Group members will be able to view and modify the value set.
    R	Group members will be able to only view the value set.
    No Access (Default)	No group members will be able to access the value set.

14. Click OK to save the permission settings.

    Note:

    The author of the value set always has the highest level of permission (R/W/D/P) on it. For example, suppose you belong to the Data Entry group and you assign the No Access permission level to the Data Entry group on a value set that you create. In this case, you will continue to have the highest level of permission on your value set; other members in your group cannot access your value set.